Journal of IiME Volume 4 Issue 1 www.investinme.org Ampligen® in Severely Debilitated CFS Patients (continued) Table 2: Drugs That Prolong the QT Interval and/or Induce Torsades de Pointes Which Were Taken by Subjects in AMP-516 Study Generic Name (Brand Name) Amitriptyline (Elavil®) Azithromycin (Zithromax®) Ciprofloxacin (Cipro®) Clarithromycin (Biaxin®) Doxepin (Sinequan®) Fluconazole (Diflucan®) Fluoxetine (Prozac®) Fluoxetine (Sarafem®) Levofloxacin (Levaquin®) Salmeterol (Serevent®) Sertraline (Zoloft®) Sumatriptan (Imitrex®) Tizanidine (Zanaflex®) Venlafaxine (Effexor®) Zolmatriptan (Zomig®) Drug Class / Clinical Usage Tricyclic Antidepressant/depression Antibiotic/bacterial infection Antibiotic/bacterial infection Antibiotic/bacterial infection Tricyclic Antidepressant/depression Anti-fungal/fungal infection Anti-depressant/depression Anti-depressant/depression Antibiotic/bacterial infection Sympathomimetic/asthma, COPD Anti-depressant/depression Migraines/cluster headaches Muscle relaxant Anti-depressant/depression Migraines suggested that, relative to placebo treatment, poly(I)·poly(C12,U) treatment is not associated with consistent increases or decreases in interferon or cytokine levels in this population. None of the group changes from Baseline to Week 32 (or last observation available) were considered to be clinically relevant. Results from the 2-factor analysis of treatment assignment and completion status revealed there was no significant difference in interferon or cytokine serum levels, suggesting similar profiles between active and placebo. Conclusion Poly(I)·poly(C12,U) treatment in this debilitated population of CFS patients resulted in a medically and statistically significant increase in exercise treadmill duration, compared to placebo. Poly(I)·poly(C12,U) treatment allowed CFS subjects to reduce their dependence on concomitant medications used to treat debilitating symptoms of CFS, coincidentally reducing exposure to drugs known to prolong the QT interval. This may suggest a new therapeutic strategy to potentially Invest in ME (Charity Nr. 1114035) mitigate the incidence of heart failure/sudden death in this relatively young predominantly female population. Poly(I)·poly(C12,U) therapy improved physical performance of CFS patients without significant modulation of serum levels of interferons α, β, γ or cytokines IL-6, IL-10, IL-12, or TNF-α. In addition, no differences were observed between poly(I)·poly(C12,U) and placebo patients in either the interferon or cytokine profiles between patients who completed the study vs. patients who discontinued early. No safety concerns were raised regarding interferon and cytokine levels and the poly(I)·poly(C12,U) therapy was generally welltolerated. Overall, there have been over 90,000 drug exposures in the combined CFS and non-CFS studies. The most frequently seen adverse event was flu-like symptoms. An integrated analysis of safety (over 1200 subjects in 13 studies) shows that poly(I)·poly(C12,U) is generally well-tolerated in both CFS and Non-CFS populations. At present, only supportive, symptom-based care is available Page 35/56
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